Drug Enforcement D-0510-2025

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

Status

Ongoing

Classification

Class II

Report Date

July 9, 2025

Termination Date

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Product Information

Product description
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
Product quantity
27,648 100-count Bottles; 5,376 500-count Bottles
Reason for recall
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
Granules Pharmaceuticals Inc.
Address
3701 Concorde Pkwy

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0510-2025
Event ID
97131
Recall initiation date
June 24, 2025
Center classification date
July 8, 2025
Code info
Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
More code info
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